Smart Urinometer: Automated ICU Urine Output Monitoring System with Real-Time Analytics
Development of an FDA-compliant smart urinometer for ICU and post-surgical patients that automatically measures urine output, flow rate, and color analysis. Eliminates manual hourly measurements, reduces nursing workload by 40%, and provides early detection of acute kidney injury (AKI).
The Challenge
A leading medical device manufacturer needed to modernize urine output monitoring in ICUs. Traditional urinometers require hourly manual readings, are prone to human error, and delay the detection of acute kidney injury - a condition that affects 50% of ICU patients.
Manual Measurement Burden
ICU nurses spend significant time on hourly urine measurements. Manual readings are often delayed, missed, or inaccurate, affecting patient care.
Impact: 12+ readings per patient/dayDelayed AKI Detection
Acute Kidney Injury develops rapidly but manual monitoring catches it 6-12 hours late. Early detection can prevent progression to kidney failure.
Impact: 50% ICU patients affectedData Silos
Handwritten urine logs are not integrated with hospital EMR systems, making trend analysis and clinical decision support impossible.
Impact: No real-time analyticsInfection Control
Frequent manual handling of urine collection systems increases infection risk. The solution needed to be a closed system with minimal contact.
Impact: CAUTI prevention criticalOur Solution
We developed an intelligent urine monitoring system that automatically measures volume, flow rate, and urine characteristics, integrates with hospital systems, and uses AI to detect early signs of kidney dysfunction.
System Architecture
Comprehensive ICU monitoring solution with bedside device, nurse station display, and cloud-based analytics.
Bedside Device
- Precision load cell for volume measurement
- Optical flow sensor for real-time flow rate
- RGB color sensor for urine analysis
- Temperature sensor for sample integrity
- Capacitive touch interface
- WiFi + BLE connectivity
Nurse Station
- Multi-patient monitoring dashboard
- Real-time alerts and notifications
- Trend visualization and reporting
- Shift handoff summaries
- Voice alert integration
Clinical Platform
- HL7 FHIR EMR integration
- AI-powered AKI prediction
- Clinical decision support
- Regulatory audit logging
- Multi-hospital analytics
Custom Hardware Design
| MCU | ESP32-S3 (WiFi + BLE + AI) |
| Load Cell | Strain gauge (0.1ml resolution) |
| Flow Sensor | Optical drop counter |
| Color Sensor | TCS34725 RGB sensor |
| Display | 2.4" TFT LCD with touch |
| Power | USB-C with battery backup |
| Protection | IPX4, IEC 60601-1 compliant |
Medical-Grade Firmware Architecture
- Real-time volume tracking with 0.1ml resolution
- Flow rate calculation with trend analysis
- Urine color classification (clear to dark amber)
- Temperature monitoring for sample quality
- Automatic hourly reporting to EMR
- AKI risk score calculation (RIFLE criteria)
- Alarm management with escalation logic
- IEC 62304 Class B compliant software lifecycle
Implementation Timeline
Phase 1: Clinical Requirements & Design
10 weeks- ICU workflow analysis and nurse interviews
- Clinical requirements with nephrologists
- Risk analysis per ISO 14971
- System architecture and design inputs
Phase 2: Hardware Development
14 weeks- Precision sensor selection and testing
- PCB design with medical-grade components
- Enclosure design for bedside mounting
- 3 prototype iterations with clinical feedback
Phase 3: Firmware Development
16 weeks- IEC 62304 compliant development process
- Sensor fusion algorithms
- Alarm management system
- EMR integration protocols
- Unit testing (96% code coverage)
Phase 4: AI Model Development
12 weeks- Training data collection (5000+ patient records)
- AKI prediction model development
- Clinical validation study design
- Edge inference optimization
Phase 5: Verification & Validation
10 weeks- IEC 60601-1 electrical safety testing
- Clinical accuracy study (200 patients)
- Usability testing with ICU nurses
- Biocompatibility assessment
Phase 6: Regulatory Submission
8 weeks- Technical documentation compilation
- CE Mark submission and review
- FDA 510(k) preparation
- Production transfer
Results & Impact
The Smart Urinometer has been deployed in 45 hospitals across India and Europe, significantly improving patient outcomes and reducing nursing workload in ICU settings.
Measurement Accuracy
vs 85% for manual readings
Nursing Time Saved
On urine monitoring tasks
AKI Detection
vs traditional monitoring
Documentation Compliance
vs 78% manual compliance
CAUTI Reduction
Fewer catheter infections
Hospitals Deployed
Across India & Europe
“The Smart Urinometer has transformed how we monitor critically ill patients. Early AKI detection has saved lives, and our nurses can focus on direct patient care instead of manual measurements.”
Head of Critical Care
Major Hospital Chain, India
Technologies Used
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